K252059
- 510(k) number
- K252059
- Device name
- CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
- Applicant
- Artivion, Inc. GA · US
- Product code
- OHA — Heart Valve, More Than Minimally Manipulated Allogra
- Decision date
- 2025-10-02
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K252059.pdf
Official FDA record: K252059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.